NCT02201082CompletedNot Applicable
Evaluation of the Timing of the Nebulization Related to the Physiotherapy Session
Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 site in 1 country15 target enrollmentStarted: September 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Urinary excretion of amikacin
Study Overview
Brief Summary
The purpose of this study is to determine the optimal time for the nebulization depending on the respiratory physiotherapy session in cystic fibrosis patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to 50 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Stable cystic fibrosis patients older than 16 y.o.
- •Pseudomonas aeruginosa colonization
- •Hypersecretion
Exclusion Criteria
- •Kidney failure
- •No pregnancy
Arms & Interventions
Nebulization and airway clearance technique
Experimental
nebulization combined to airway clearance
Intervention: Airway clearance technique (Procedure)
Nebulization and airway clearance technique
Experimental
nebulization combined to airway clearance
Intervention: Amikacin nebulization (Drug)
Nebulization
Active Comparator
nebulization
Intervention: Amikacin nebulization (Drug)
Outcomes
Primary Outcomes
Urinary excretion of amikacin
Time Frame: 24h after the nebulization
Pharmacokinetic study of the urinary excretion of amikacin after nebulization
Secondary Outcomes
- Amikacin concentration into the sputum(At the end of the nebulization, an expected average of 20 minutes)
Investigators
Study Sites (1)
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